Trial to Compare the Efficacy and Safety of a Single Bolus of TNK-tPA (Tenecteplase, Metalyse®) With Accelerated Infusion of Rt-PA (Alteplase, Actilyse®) in Asian Patients With Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148460
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : October 29, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:
The objective of this trial was to compare the efficacy and safety of a single bolus of TNK-tPA (tenecteplase, Metalyse®) compared with rt-PA (alteplase, Actilyse®) in Asian patients.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: TNK-tPA Drug: rt-PA Phase 3

Detailed Description:

This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy and safety of TNK-tPA (tenecteplase, Metalyse®) with that of accelerated rt-PA (alteplase, Actilyse®) in Asian patients with AMI. The primary endpoint (TIMI 3 Flow) and the secondary endpoint (TIMI frame count) were evaluated in a blinded manner in the core laboratory.

Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups (i.e. TNK-tPA or accelerated rt-PA).

The study period totaled 30-37 days and included baseline, randomisation, study drug administration, in-hospital follow-up and thirty-day follow-up.

Coronary angiography was performed at 90 minutes after the start of study drug administration. 12-lead electrocardiograms (ECGs) were obtained before randomization, between 60 to 75 minutes and 180 ± 15 minutes after the start of study drug administration, and at hospital discharge.

If the patient showed rapid and progressive hemodynamic deterioration before 90 minutes, rescue PTCA or other appropriate interventions should be performed at the discretion of the treating physician.

Following the analysis of TIMI flow and frame count at each study center, the results were carefully recorded on the CRFs. This data was stored on a compact disk or a film and labeled with the subject's study I.D. number. It was then sent with the summary worksheets and ECGs to the Angiographic Core Laboratory located at the Leuven Coordinating Center (LCC) of the University Hospital Gasthuisberg (Leuven, Belgium) for central evaluations.

Study Hypothesis:

The null hypothesis tested was that there was no difference between the two treatment groups: TNK-tPA (Tenecteplase, Metalyse®) and accelerated rt-PA (Actilyse®), against the alternative that there was a difference.


The primary endpoint of the study was TIMI 3 flow at 90 minutes after start of thrombolytic therapy, angiograms were evaluated in a blinded manner in a core laboratory.

Study Type : Interventional  (Clinical Trial)
Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Open-label, Multi-center, Angiographic Trial to Compare the Efficacy and Safety of Single Bolus of Tenecteplase (Metalyse®) With Accelerated Infusion of Alteplase in Asian Patients With Acute Myocardial Infarction
Study Start Date : March 2001
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Primary Outcome Measures :
  1. The percentage of patients with thrombolysis in myocardial infarction (TIMI) grade 3 flow in the infarct-related artery (IRA) [ Time Frame: at 90 minutes after the start of thrombolytic treatment ]

Secondary Outcome Measures :
  1. Infarct-related artery patency [ Time Frame: at 90 minutes ]
  2. The percentage of subjects with ST-segment resolution [ Time Frame: at 60 and 180 minutes ]
  3. Mortality [ Time Frame: 30-days ]
  4. Safety
  5. The effects of TNK-tPA on coagulation and fibrinogenolysis (at selected clinical sites)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age >= 18 and <= 75 years.
  2. Asian origin.
  3. Ischemic discomfort >= 30 minutes in duration.
  4. Onset of acute myocardial infarction (AMI) symptoms within 6 hours prior to randomization.
  5. A twelve lead electrocardiogram (ECG) with one of the following:

    • ST segment elevation >= 0.1 mV in two or more limb leads; or
    • >= 0.2 mV in two or more contiguous precordial leads indicative of AMI.
  6. Ability to give informed consent.

Exclusion Criteria:

  1. Previous coronary artery bypass grafting (CABG) surgery.
  2. Cardiogenic shock (e.g. systolic blood pressure [SBP] < 90 mmHg).
  3. Systolic blood pressure (SBP) >= 180 mmHg and/or diastolic blood pressure (DBP) >= 110 mmHg during current admission on one reliable measurement prior to randomization.
  4. Inability to undergo cardiac catheterization.
  5. Significant bleeding disorder either at present or within the past 6 months.
  6. Major surgery, biopsy of a parenchymal organ, or significant trauma within 3 months.
  7. Any minor head trauma and/or any other trauma that occurred after onset of current myocardial infarction.
  8. Use of heparin, GPIIb/IIIa antagonists or other anticoagulants within the last 2 weeks.
  9. Any known history of stroke or transient ischemic attack or central nervous system structural damage (i.e. neoplasm, aneurysm, intracranial surgery).
  10. Prolonged cardiopulmonary resuscitation (> 10 minutes) within 2 weeks.
  11. Pregnancy, lactation or parturition within the previous 30 days. Women of childbearing potential must have had a negative pregnancy test and must have used a medically accepted method of birth control (i.e. uterine device, surgical sterilisation, progestogens alone).
  12. Previous treatment with TNK-tPA (tenecteplase).
  13. Inability to follow protocol and comply with follow-up.
  14. Drug abuse within the last year.
  15. Participation in another clinical trial within the previous 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00148460

Beijing An Zhen Hospital
Beijing, China, 100029
Beijing University
Beijing, China, 100044
Beijing Friendship Hospital
Beijing, China, 100050
Beijing Xuan Wu Hospital
Beijing, China, 100050
Bejing Tongren Hospital
Beijing, China, 100730
Center Hospital of Dalian
Dalian, China, 116033
Center Hospital of Jinan
Jinan, China, 250013
Fudan University
Shanghai, China, 200032
People's Hospital of Liaoning Province
Shenyang, China, 110015
Hong Kong
The University of Hong Kong, Cardiology Division
Hong Kong, Hong Kong
Korea, Republic of
Dongsan Medical Center
Jung-Ku, Korea, Republic of, 700711
Chunnam University Hospital
Kwang-Ju, Korea, Republic of, 501757
Dong-A University Hospital
Pusan, Korea, Republic of, 602715
Seoul National University Hospital
Seoul, Korea, Republic of, 100744
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120752
Seoul Joongang Hospital
Seoul, Korea, Republic of, 138736
A-Jou University Hospital
Suwon, Korea, Republic of, 443721
Wonju Christian Hospital (Yonsei University Hosp)
Wonju, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai Identifier: NCT00148460     History of Changes
Other Study ID Numbers: 1123.8
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action